Fascial Defect Closure for Minimally Invasive Parastomal Hernia Repair

NCT05514600 | Terminated

• 1 other identifier: 22-634
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Fascial closure was not originally a routine component of minimally invasive parastomal hernia repairs, but several recent advancements have made fascial closure more common in this context. These include barbed self-locking sutures that aid intracorporeal fascial closure under tension, and wristed instrumentation offered by the robotic platform when available. The investigator aims to characterize the clinical significance of closing the fascia adjacent to the stoma during a MIS parastomal hernia repair. The investigator hypothesizes that fascial closure will not have a significant impact on postoperative stoma specific quality of life but will reduce long-term recurrence.

Conditions

Parastomal Hernia

Outcome Measures

Primary Outcomes (1)

• Stoma specific quality of life score (1 year)

  The investigators will compare stoma-specific quality of life score using the Colostomy Impact Score (a patient reported survey with 7 questions with a range of 0-38 and higher scores indicating more negative impact on quality of life) at 1 year +/-4 months after minimally invasive Sugarbaker parastomal repair with and without parastomal fascial closure.

  1 year

Secondary Outcomes (10)

• Stoma specific quality of life score (30 days)

  30 days

• Stoma specific quality of life score (2 years)

  2 years

• Recurrence

  2 years

• Pain Intensity

  2 years

• Abdominal Wall Specific Quality of Life

  2 years

Study Arms (2)

Fascial closure

ACTIVE COMPARATOR

This arm will have the parastomal fascial defect closed with a running barbed suture prior to mesh placement.

Procedure: closure of parastomal hernia fascial defect

No fascial closure

NO INTERVENTION

This arm will undergo mesh placement +/- fixation without the fascial defect being closed prior.

Interventions

closure of parastomal hernia fascial defect PROCEDURE

For subjects randomized to the fascial closure arm, the parastomal defect will be closed using barbed, running suture prior to placement of the mesh.

Fascial closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years or older
• End or loop-end stoma with a parastomal defect - candidate for minimally invasive Sugarbaker repair at the discretion of the staff surgeon.
• Anticipated parastomal fascial defect should not exceed 7cm in any direction
• Patient able to tolerate a minimally invasive repair, the surgeon can achieve minimally invasive access and complete a minimally invasive adhesiolysis.
• Bowel able to be lateralized at least 4cm beyond the edge of the parastomal fascial defect

You may not qualify if:

• Loop stoma
• Parastomal fascial defect \>7cm
• Concomitant ventral defect or complexity of the repair warrants open repair at the discretion of the staff surgeon
• Minimally invasive Sugarbaker repair with intraperitoneal mesh cannot be achieved.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FACS

Study Record Dates

• First Submitted: August 6, 2022
• First Posted: August 24, 2022
• Study Start: September 8, 2022
• Primary Completion: May 20, 2023
• Study Completion: May 20, 2023
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

US (1)